Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Cook Medical

Limerick, Ireland

Overview

The primary role of the Senior Regulatory Affairs Specialist is to assist in the running of the regulatory affairs by providing input into: regulatory strategies, performing activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets and providing regulatory affairs input for the functional areas.

Function will involve a thorough understanding of the regulatory requirements required for the Medical Device Industry.

Reporting to: Regulatory Affairs Manager

Responsibilities

Assists in the running of the Cook Ireland regulatory affairs programmes in accordance with internal procedures and regulatory requirements;

Responsibility for assisting in implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA 21CFR Part 820 as required and other jurisdictions as required;

Maintains an excellent understanding of the global medical device regulations;

Maintains a thorough understanding of the products assigned to the team;

Works to improve the function of the Regulatory Affairs Department;

Understands the progress of the RA team on assigned tasks, and removes roadblocks;

Provides support to the RA team members to complete assigned tasks;

Mentors and trains new RA team members;

Highlights any updates to regulatory requirements to regulatory management;

Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as needed or collaborates with their assigned regulatory specialists on same;

Reviews submissions generated for their assigned regulatory area to ensure compliance to the regulations in that particular jurisdiction;

Serves as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner;

Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required;

Maintains a system for registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability;

Provides support to currently marketed products as necessary including input on change requests, etc.;